Washington – Patients who take Tamiflu should be closely monitored for signs of abnormal behavior, health officials said Monday in announcing an updated label for the flu drug.
The added precaution comes after reports of more than 100 new cases of delirium, hallucinations and other unusual psychiatric behavior in children treated with the drug. Most were Japanese children.
The Food and Drug Administration said a relationship between the drug and the behavior had not been established and that the updated label was “intended to mitigate a potential risk associated with Tamiflu.”
It recommends that close monitoring begin immediately after starting treatment with the drug.
The FDA said it had received 103 reports, mostly from Japan, of injury and delirium among the millions of flu patients treated with Tamiflu. The changes bring the U.S. label more in line with the Japanese one, which already warned such abnormal behavior could occur. The previous FDA-approved label mentioned “seizure and confusion” seen in some patients.
Tamiflu is made by the Swiss pharmaceutical company Roche Holding AG. Roche spokesman Terence Hurley said there was no evidence the drug caused the rarely occurring adverse events.
Both Roche and the FDA also said that severe cases of the flu can spark the abnormal behavior flagged in the updated label.
In documents released Monday, FDA staff acknowledged that stopping treatment with Tamiflu could harm influenza patients if the virus is the cause of delirium, hallucinations and other abnormal behavior, such as aggression and suicidal thoughts.
According to the label, Tamiflu is for the treatment of uncomplicated acute illness due to flu in patients 1 year and older who have shown symptoms for no more than two days.
